Quality Control Associate
vor 2 Monaten
The Associate II Quality Control is primarily responsible for managing various aspects of sample handling and documentation within the Quality Control department. This includes sample management, shipment coordination, ordering and distribution of reagents and consumables, equipment management, and authoring and reviewing GMP documentation.
**Responsibilities**:
- **Sample Management (25%)**:
- Manage QC test, stability, and retain samples, ensuring compliance with GMP standards.
- Coordinate the preparation, movement, and shipping of samples to internal and external locations, maintaining chain of custody.
- Utilize Laboratory Information Management System (LIMS) and enterprise resource planning systems (e.g., Oracle) for sample tracking and documentation.
- **Aliquotation & Sub-sampling (15%)**:
- Perform aliquotation and sub-sampling of drug substance bags to generate QC samples, ensuring sample integrity.
- **Sample Shipment Coordination (25%)**:
- Organize and coordinate sample shipments for various purposes, including raw material samples, material science samples, and shipments to partner organizations and Contract Laboratories (CLOs).
- **Support Operations (15%)**:
- Support day-to-day operations within Central and Work-In-Progress (WIP) laboratories.
- Manage work orders for non-analytical testing equipment like freezers.
- **Reagent and Consumable Management (10%)**:
- Order, manage, and distribute QC-related reagents and consumables across all QC laboratories on-site.
- Collaborate with vendor managed inventory (VMI) system personnel.
- Prepare solutions required for analytical testing, such as liquid chromatography buffers and TOC testing solutions.
- **GMP Documentation (10%)**:
- Author, review, and approve complex GMP documentation, including plans, protocols, procedures, specifications, Corrective and Preventive Actions (CAPAs), and deviations.
**Requirements**:
- Education: Associate's Degree or Bachelor's Degree in a relevant field.
- Experience:
- 1-2 years of technical experience, preferably in pharmaceutical or biotech manufacturing.
- Prior experience in a GMP Quality Control function and familiarity with purchasing quality-controlled goods is advantageous
- Knowledge & Skills:
- Proficiency in German and English
- Basic knowledge of Microbiology and Chemistry.
- Skills in buffer and solution preparation desired.
- Familiarity with aseptic working environments.
- Strong organizational and communication skills.
- Proficiency in productivity software (Word, Excel, Outlook).
- Ideally experienced with LabWare LIMS and Oracle system.
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